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Monitoring Pre-exposure Prophylaxis for Young Adult Women (MPYA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02915367
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
University of Washington
Kenya Medical Research Institute
Information provided by (Responsible Party):
Jessica Haberer, MD, Massachusetts General Hospital

Brief Summary:
Next generation real-time monitoring for PrEP adherence in young Kenyan women

Condition or disease Intervention/treatment Phase
HIV/AIDS Adherence Behavioral: SMS Reminders Not Applicable

Detailed Description:
This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered HIV pre-exposure prophylaxis (PrEP) for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive short message service (SMS) reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women
Actual Study Start Date : December 21, 2016
Actual Primary Completion Date : March 20, 2020
Actual Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: SMS Reminders
Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
Behavioral: SMS Reminders
Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).

No Intervention: No Reminders
Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.



Primary Outcome Measures :
  1. Enacted adherence as measured by Wisepill data and tenofovir concentration on dried blood spots at 6 months [ Time Frame: up to 2 years follow-up ]
    Difference in adherence by study arm


Secondary Outcome Measures :
  1. Acceptability [ Time Frame: up to 2 years follow-up ]
    Qualitative interviews

  2. Cost-effectiveness [ Time Frame: up to 2 years follow-up ]
    Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted


Other Outcome Measures:
  1. Risk perception [ Time Frame: up to 2 years follow-up ]
    Compare adherence by self-reported weekly HIV risk perception

  2. Adherence measure performance [ Time Frame: up to 2 years follow-up ]
    Concordance between Wisepill openings and blood levels of tenofovir

  3. Pregnancy outcomes [ Time Frame: up to 6 months post-partum ]
    Descriptive measures of infants exposed to PrEP during gestation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV-uninfected (as determined by Kenya national testing algorithms)
  • Wanting to start PrEP with an initial recommendation of 6 months of use
  • Clinically safe to receive PrEP, in accordance with Centers for Disease Control and Prevention (CDC) guidelines:

    • Creatinine clearance >60 mL/min
    • Not infected with hepatitis B
    • No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study
  • Sexually active (defined as vaginal or anal sex) within the last 3 months
  • At high risk for HIV infection based on a validated risk score of >5 or being in an HIV serodiscordant relationship
  • Not pregnant
  • Owns a personal cell phone (not shared) compatible with study protocols and the ability to charge it
  • Ability to send a text message
  • Intending to stay in the area for at least the next year
  • Willing to use study criteria

Exclusion Criteria:

  • Unable to provide consent
  • Breast-feeding (PrEPis not currently approved for use during breast-feeding)
  • Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915367


Locations
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Kenya
KEMRI
Kisumu, Kenya
KEMRI
Thika, Kenya
Sponsors and Collaborators
Massachusetts General Hospital
University of Washington
Kenya Medical Research Institute
Investigators
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Principal Investigator: Jessica Haberer, MD, MS Massachussetts General Hospital
Principal Investigator: Jared Baeten, MD, PhD University of Washington
Study Director: Nelly Mugo Kenya Medical Research Institute
Study Director: Elizabeth Bukusi Kenya Medical Research Institute
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Responsible Party: Jessica Haberer, MD, Research Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02915367    
Other Study ID Numbers: R01MH109309 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available at the end of the study upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available within 12 months of publishing primary results
Access Criteria: Data use agreement
Keywords provided by Jessica Haberer, MD, Massachusetts General Hospital:
HIV/AIDS
adherence
women
real time monitoring
risk
SMS
mHealth